Needleless connector with a tortuous fluid flow path

ABSTRACT

A needleless connector has a housing with an internal cavity having an interior surface, a port, an output flow channel, and a fluid flow path through the cavity between the port and the output flow channel. A collapsible valve is disposed within the cavity. The valve has one or more rings each having a surface that is in sealing contact with the interior surface of the housing. There are one or more notches formed in each of the one or more rings, and the flow path passes through one of the notches in each of the one or more rings.

CROSS-REFERENCES TO RELATED APPLICATIONS

Not applicable.

BACKGROUND

1. Field

The present disclosure generally relates to needleless connectors, and,in particular, to connectors with a tortuous fluid flow path.

2. Description of the Related Art

Medical treatments often include the infusion of a medical fluid, forexample a saline solution or a liquid medication, to patients using anintravenous (IV) catheter that is connected though an arrangement offlexible tubing and fittings, commonly referred to as an “IV set,” to asource of fluid, for example an IV bag. The fittings commonly includeinterconnectable male and female needleless connectors having a “Luertaper” conforming to an International Standards Organization (ISO)standard. Certain connectors have a self-sealing feature to preventleakage of fluid from the attached tubing when the connector isdecoupled from a mating connector.

One conventional needleless connector 10, shown in FIGS. 1A-1B, has acollapsible internal valve 20 made of a flexible material. When a forceis applied to the top 22 of the valve 20 by the tip of a male Luerfitting 40, the valve 20 folds at a “smiley cut” 24 located in an upperportion of the valve 20, thereby opening a flow path 12 through theconnector 10. The flow path 12 is generally linear between thecylindrical body 26 of the valve 20 and the body 32 and then through thebase 34 into a mated female Luer fitting 50. This flow path 12 may notflush certain regions within the fluid-filled space within connector 10.As some medical fluids degrade with time, this non-flushed portion ofthe fluid may present a hazard to a patient.

SUMMARY

The self-sealing needleless female Luer connector disclosed hereinprovides a tortuous path through the connector such that fluid flowingthrough the connector flushes the entire path, thereby reducing thenon-flushed portion of the fluid-filled volume within the connector.

In certain embodiments, a needleless connector is disclosed thatincludes a housing having an internal cavity with an interior surface, aport, an output flow channel, and a fluid flow path through the cavitybetween the port and the output flow channel. The connector alsoincludes a collapsible valve disposed within the cavity. The valve hasone or more rings each having a respective surface in sealing contactwith the interior surface of the housing, with one or more notchesformed in each of the one or more rings. The flow path passes throughone of the one or more notches in each respective one of the one or morerings.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide furtherunderstanding and are incorporated in and constitute a part of thisspecification, illustrate disclosed embodiments and together with thedescription serve to explain the principles of the disclosedembodiments. In the drawings:

FIGS. 1A-1B are cross-sections of a conventional needleless connector.

FIGS. 2A-2C are perspective views of an exemplary needleless connectoraccording to certain aspects of the present disclosure.

FIG. 3 is a cross-section of the exemplary valve in an unactuatedposition according to certain aspects of the present disclosure.

FIGS. 4A-4B are cross-sections of the exemplary valve in an actuatedposition according to certain aspects of the present disclosure.

FIG. 5 is a three-dimensional flow diagram of a flow path through theexemplary connector according to certain aspects of the presentdisclosure.

DETAILED DESCRIPTION

It is advantageous to provide a self-sealing, needleless connector thataccepts male Luer fittings that meet the ISO standard and has aninternal flow path that reduces, compared to conventional connectors,the portion of the fluid-filled volume that is not flushed by fluidflowing through the disclosed connector.

In the following detailed description, numerous specific details are setforth to provide a full understanding of the present disclosure. It willbe apparent, however, to one ordinarily skilled in the art thatembodiments of the present disclosure may be practiced without some ofthe specific details. In other instances, well-known structures andtechniques have not been shown in detail so as not to obscure thedisclosure. In the referenced drawings, like numbered elements are thesame or essentially similar. Reference numbers may have letter suffixesappended to indicate separate instances of a common element while beingreferred to generically by the same number without a suffix letter.

FIGS. 1A-1B are cross-sections of a conventional needleless connector10. FIG. 1A depicts a collapsible valve 20 that is disposed in thehousing top 32 of the connector 10, as shown in FIG. 1B. The valve 20has a solid head with a “smiley cut” 24 formed on one side and a topsurface 22. The valve has a cylindrical body 26 with a hollow interior27. There is a shoulder 28 above the cylindrical portion 26.

FIG. 1B depicts the connector 10 in the activated position, i.e. a maleLuer fitting 40 sealingly coupled to the connector 10 at port 36. Thetip of the male Luer fitting 40 has displaced the external surface 22downward and the applied force has caused the upper portion of the valve20 to buckle toward the smiley cut 24 as well as causing the cylindricalwall 26 to buckle. In the activated configuration, the primary sealbetween the shoulder 28 and ridge 35 of the housing top 32, which are incontact when the connector 10 is in an unactuated position, is openedsuch that fluid may flow through the connector 10, as indicated by thefluid flow path 12 that passes from the male Luer fitting 40 between thetop housing 32 and the valve 20 and then through channels 38 in the base34 and out through a connected female Luer fitting 50. A needlelessconnector similar to the connector 10 described herein is described indetail in U.S. patent application Ser. No. 12/512,719, the entirety ofwhich is hereby incorporated by reference.

While the conventional needleless connector 10 of FIGS. 1A-1B allows theconnection and disconnection of a male Luer fitting and seals the flowpath 12 when there is no fitting mated with the connector 10, it isgenerally desirable to have the fluid-filled space within the connector10 fully flushed as fluid flows through the connector 10. With agenerally linear flow path, as indicated by the example flow path 12,certain portions of the fluid-filled volume of connector 10 may not beflushed, which may result in some medication remaining the connector foran extended period of time. As medications may degrade over time, it isdesirable to fully flush the fluid-filled volume within a needlelessconnector.

FIGS. 2A-2C are perspective views of an exemplary needleless connector100 according to certain aspects of the present disclosure. FIG. 2A is aperspective view of an assembled connector 100, showing how the unbrokentop surface 126 of a collapsible valve 120 blocks the port 116 andpresents a smooth surface that can easily be disinfected prior to use.

FIG. 2B is an exploded view of the connector 100, showing how thecollapsible valve 120 is captured between a lower housing 130 and anupper housing 110.

FIG. 2C is an enlarged view of the internal valve 120, showing a smileycut 121 and a shoulder 128 that function in a manner similar to thesmiley cut 24 and shoulder 28 of the conventional connector 10. Theexemplary collapsible valve 120 has, in this embodiment, three sealingrings 122 disposed between the shoulder 128 and base 123. Each ring 122has a cylindrical outer surface that is interrupted at one or morelocations by a notch 124 that passes vertically through the respectivering 122. Each ring 122 has at least one notch 124, with the notches 124of adjoining rings 122 offset circumferentially from each other. Incertain embodiments, there are two notches 124 in each ring 122, withthe two notches circumferentially disposed 180° from each other. Incertain embodiments, the at least one notch 124 of a first ring iscircumferentially disposed 90° from the notch 124 of a second ring 122that is adjacent to the first ring 122. In certain embodiments, thenotches 124 may be formed as simple interruptions of the ring 122 while,in other embodiments, the notches 124 may incorporate features such asribs, bumps, or tapered surfaces, such as the bump 127 shown in FIG. 2C.

FIG. 3 is a cross-section of the exemplary valve 100 in an unactuatedposition according to certain aspects of the present disclosure. Theshoulder 128 is in contact with a ridge 112 of the upper housing 110,thereby forming a primary seal that blocks flow through the connector100. The lower housing 130 has an output flow path 132. The lowerhousing 130 and upper housing 110 are, in this example, ultrasonicallywelded to each other at location “W.” In certain embodiments, the upperand lower housings 110, 130 may be sealingly joined using any methodknown to those of skill in the art, including bonding, solvent welding,spin welding, etc. The cylindrical surfaces of the rings 122 are insealing contact with a cylindrical interior surface 114 of the upperhousing 110. In this cross-sectional view, it can be seen that the valve120 is hollow and the interior surface follows the contours of the rings122, thereby forming a bellows 125 under each ring 122.

FIGS. 4A-4B are cross-sections of the exemplary valve 100 in anunactuated position according to certain aspects of the presentdisclosure. FIG. 4A shows the entire connector 100 with a male Luerfitting 40 sealingly mated with the port 116 and displacing the topsurface 126 downward, causing the top portion of the collapsible valve120 to fold around the smiley cut 121 and partially collapsing thebellows 125. As a result of the smiley cut 121 folding, the top surface126 is canted such that there is a gap between the end of the male Luerfitting 40 such that fluid can enter the connector 100 from the maleLuer fitting 40. The cylindrical surfaces of the rings 122 slide alongthe interior surface 114 and remain in sealing contact with the surface114.

FIG. 4B is an enlarged view of the portion of FIG. 4A indicated by thedashed-line box labeled “4B.” It can be seen on the left side, as viewedin FIG. 4B, of the valve 120 that each of rings 122 are in sealingcontact with the interior surface 114, as indicated in the example areaindicated by the circle labeled “A.” On the right side of collapsiblevalve 120, it can be seen that the notches 124 provide a flow path pastthe respective rings 122, as indicated by the circles labeled “B.” Aseach ring 122 has at least one notch 124, with the notches 124 ofadjoining rings 122 offset circumferentially from each other, fluid mayflow a tortuous path that includes a notch 124 of each ring 122 and aportion of the toroidal flow channel 102 that is formed between pairs ofadjacent rings 122 and the interior surface 114, as discussed in greaterdetail with respect to FIG. 5.

FIG. 5 is a three-dimensional flow diagram of a flow path 104 throughthe exemplary connector 100 according to certain aspects of the presentdisclosure. The upper and lower housings 110 and 130 are shown inphantom so as to provide a view of the internal flow paths. FIG. 5displays a plurality of different flow paths, as calculated by a flowsimulation software package, wherein a single example flow path isindicated by the path labeled 104. Fluid enters from the mated male Luerconnector 40 and flows past the canted top 126 of the collapsible valve120 and down to the first ring 122. The fluid travels circumferentiallyaround a portion of the collapsible valve 120 to reach the notch 124 inthe first ring 122A and then flows through the notch 124. The fluid thenflows circumferentially through the first toroidal flow channel 102A tothe notch 124 in the second ring 122B, which is disposed 90° from thenotch 124 of the first ring 122A. The fluid flows through the notch 124and then back through a second toroidal flow channel 102B to a notch inthe third ring 122C. The fluid then flows through the notch 124 and downpast the base 123 in a channel 125 and out through the base 130.

It can be seen that the disclosed embodiments of the needlelessconnector 100 provide a tortuous path 104 through the fluid-filledvolume within the connector 100 so as to reduce or eliminate portions ofthe fluid-filled space that are not flushed by the flow of fluid. Incertain embodiments, there may be more or fewer notches 124 in each ring122 and, in certain embodiments, there may be a different number ofnotches 124 in each ring 122. In certain embodiments, the channel 125may be offset from the notch 124 in the lowest ring 122 so as to causeadditional circumferential flow between the lowest ring 122 and the base123. In certain embodiments, the notches may be distributedsymmetrically about the ring 122 while, in certain other embodiments,the notches may not be distributed evenly.

In summary, the rings and notches of the disclosed needleless connectorcooperate to form a tortuous flow path through the connector thatreduces the portion of the fluid-filled interior volume that is notflushed by fluid flowing through the connector. By forcing the fluid toflow circumferentially between the rings, the volumes that are notflushed by the linear flow of a conventional valve are coupled to theflow path. Various combinations of rings and notches may be utilized toforce this circumferential flow while reducing the pressure drop acrossthe connector.

The previous description is provided to enable any person skilled in theart to practice the various aspects described herein. While theforegoing has described what are considered to be the best mode and/orother examples, it is understood that various modifications to theseaspects will be readily apparent to those skilled in the art, and thegeneric principles defined herein may be applied to other aspects. Thus,the claims are not intended to be limited to the aspects shown herein,but is to be accorded the full scope consistent with the languageclaims, wherein reference to an element in the singular is not intendedto mean “one and only one” unless specifically so stated, but rather“one or more.” Unless specifically stated otherwise, the terms “a set”and “some” refer to one or more. Pronouns in the masculine (e.g., his)include the feminine and neuter gender (e.g., her and its) and viceversa. Headings and subheadings, if any, are used for convenience onlyand do not limit the invention.

To the extent that the terms “include,” “have,” “with,” and the like areused in the description or the claims, such terms are intended to beinclusive in a manner similar to the term “comprise” as “comprise” isinterpreted when employed as a transitional word in a claim.

It is understood that the specific order or hierarchy of steps in theprocesses disclosed is an illustration of exemplary approaches. Basedupon design preferences, it is understood that the specific order orhierarchy of steps in the processes may be rearranged. Some of the stepsmay be performed simultaneously. The accompanying method claims presentelements of the various steps in a sample order, and are not meant to belimited to the specific order or hierarchy presented.

Terms such as “top,” “bottom,” “front,” “rear” and the like as used inthis disclosure should be understood as referring to an arbitrary frameof reference, rather than to the ordinary gravitational frame ofreference. Thus, a top surface, a bottom surface, a front surface, and arear surface may extend upwardly, downwardly, diagonally, orhorizontally in a gravitational frame of reference.

A phrase such as an “aspect” does not imply that such aspect isessential to the subject technology or that such aspect applies to allconfigurations of the subject technology. A disclosure relating to anaspect may apply to all configurations, or one or more configurations. Aphrase such as an aspect may refer to one or more aspects and viceversa. A phrase such as an “embodiment” does not imply that suchembodiment is essential to the subject technology or that suchembodiment applies to all configurations of the subject technology. Adisclosure relating to an embodiment may apply to all embodiments, orone or more embodiments. A phrase such an embodiment may refer to one ormore embodiments and vice versa.

The word “exemplary” is used herein to mean “serving as an example orillustration.” Any aspect or design described herein as “exemplary” isnot necessarily to be construed as preferred or advantageous over otheraspects or designs.

All structural and functional equivalents to the elements of the variousaspects described throughout this disclosure that are known or latercome to be known to those of ordinary skill in the art are expresslyincorporated herein by reference and are intended to be encompassed bythe claims.

Nothing disclosed herein is intended to be dedicated to the publicregardless of whether such disclosure is explicitly recited in theclaims. No claim element is to be construed under the provisions of 35U.S.C. §112, sixth paragraph, unless the element is expressly recitedusing the phrase “means for” or, in the case of a method claim, theelement is recited using the phrase “step for.”

What is claimed is:
 1. A needleless connector comprising: a housinghaving an internal cavity with an interior surface, a port, an outputflow channel, and a fluid flow path through the cavity between the portand the output flow channel; and a collapsible valve disposed within thecavity, the valve comprising: at least two rings each having arespective surface in sealing contact with the interior surface of thehousing; and one or more notches formed in each of the at least tworings, wherein the one or more notches in a first ring of the at leasttwo rings are circumferentially offset from the one or more notches in asecond ring of the at least two rings that is adjacent to the firstring, the one or more notches in at least one of the at least two ringscomprise two notches circumferentially disposed 180° from each other,wherein the fluid flow path passes through one of the one or morenotches in each of the at least two rings.
 2. The needleless connectorof claim 1, wherein the interior surface and the respective surfaces ofthe at least two rings are cylindrical.
 3. The needleless connector ofclaim 1, further comprising one or more toroidal flow channels formedbetween adjacent rings of the at least two rings and the interiorsurface of the housing, wherein the flow path passes through one of theone or more notches in a first ring of the at least two rings, along aportion of a toroidal flow channel that is formed between the firstring, a second ring of the at least two rings that is adjacent to thefirst ring, and the interior surface of the housing, and then throughone of the one or more notches in the second ring.
 4. The needlelessconnector of claim 1, wherein: a first ring of the at least two ringscomprises two notches circumferentially disposed 180° from each other;and a second ring of the at least two rings is adjacent to the firstring and comprises two notches circumferentially disposed 180° from eachother and circumferentially offset from the two notches of the firstring by 90°.
 5. The needleless connector of claim 1, wherein the valvefurther comprises one or more bellows respectively formed under the oneor more rings, the bellows configured to partially collapse as theneedleless valve moves from an unactuated position to an actuatedposition while allowing the respective surfaces of the one or more ringsto remain in sealing contact with the interior surface.
 6. Theneedleless connector of claim 1, wherein the valve further comprises asmiley cut proximate the port, wherein a portion of the valve foldsaround the smiley cut when the needleless connector is in an actuatedposition.
 7. The needleless connector of claim 1, wherein: the valvefurther comprises a shoulder; and the housing further comprises a ridgedisposed on the interior surface and configured to sealingly contact theshoulder when the needleless connector is in an unactuated position soas to block the fluid flow path.
 8. The needleless connector of claim 1,wherein the valve further comprises an unbroken top surface that isflush with the port of the housing when the needleless connector is inan unactuated position.
 9. The needleless connector of claim 1, whereina portion of the housing that is proximate to the port is configured tosealingly mate with a male Luer fitting.
 10. A needleless connectorcomprising: a housing having an internal cavity with an interiorsurface, a port, an output flow channel, and a fluid flow path throughthe cavity between the port and the output flow channel; a collapsiblevalve disposed within the cavity, the valve comprising: at least tworings each having a respective surface in sealing contact with theinterior surface of the housing; and one or more notches formed in eachof the at least two rings, wherein the one or more notches in a firstring of the at least two rings are circumferentially offset from the oneor more notches in a second ring of the at least two rings that isadjacent to the first ring; and one or more toroidal flow channelsformed between adjacent rings of the at least two rings and the interiorsurface of the housing, wherein the flow path passes through one of theone or more notches in a first ring of the at least two rings, along aportion of a toroidal flow channel that is formed between the firstring, a second ring of the at least two rings that is adjacent to thefirst ring, and the interior surface of the housing, and then throughone of the one or more notches in the second ring, wherein the fluidflow path passes through one of the one or more notches in each of theat least two rings.
 11. The needleless connector of claim 10, whereinthe interior surface and the respective surfaces of the at least tworings are cylindrical.
 12. The needleless connector of claim 10,wherein: a first ring of the at least two rings comprises two notchescircumferentially disposed 180° from each other; and a second ring ofthe at least two rings is adjacent to the first ring and comprises twonotches circumferentially disposed 180° from each other andcircumferentially offset from the two notches of the first ring by 90°.13. The needleless connector of claim 10, wherein the valve furthercomprises one or more bellows respectively formed under the one or morerings, the bellows configured to partially collapse as the needlelessvalve moves from an unactuated position to an actuated position whileallowing the respective surfaces of the one or more rings to remain insealing contact with the interior surface.
 14. The needleless connectorof claim 10, wherein the valve further comprises a smiley cut proximatethe port, wherein a portion of the valve fold around the smiley cut whenthe needleless connector is in an actuated position.
 15. The needlelessconnector of claim 10, wherein: the valve further comprises a shoulder;and the housing further comprises a ridge disposed on the interiorsurface and configured to sealingly contact the shoulder when theneedleless connector is in an unactuated position so as to block thefluid flow path.
 16. The needleless connector of claim 10, wherein thevalve further comprises an unbroken top surface that is flush with theport of the housing when the needleless connector is in an unactuatedposition.
 17. The needleless connector of claim 10, wherein a portion ofthe housing that is proximate to the port is configured to sealing matewith a male Luer fitting.